根据镇静方法评估内镜黏膜下剥离术中操作的稳定性和安全性：一项随机试验。
Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial.
作者信息
Park Chan Hyuk, Shin Seokyung, Lee Sang Kil, Lee Hyuk, Lee Yong Chan, Park Jun Chul, Yoo Young Chul
机构信息
Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
Department of Anesthesiology and Pain Medicine, Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea.
出版信息
PLoS One. 2015 Mar 24;10(3):e0120529. doi: 10.1371/journal.pone.0120529. eCollection 2015.
BACKGROUND
Although endoscopic submucosal dissection (ESD) is routinely performed under sedation, the difference in ESD performance according to sedation method is not well known. This study attempted to prospectively assess and compare the satisfaction of the endoscopists and patient stability during ESD between two sedation methods.
METHODS
One hundred and fifty-four adult patients scheduled for ESD were sedated by either the IMIE (intermittent midazolam/propofol injection by endoscopist) or CPIA (continuous propofol infusion by anesthesiologist) method. The primary endpoint of this study was to compare the level of satisfaction of the endoscopists between the two groups. The secondary endpoints included level of satisfaction of the patients, patient's pain scores, events interfering with the procedure, incidence of unintended deep sedation, hemodynamic and respiratory events, and ESD outcomes and complications.
RESULTS
Level of satisfaction of the endoscopists was significantly higher in the CPIA Group compared to the IMIE group (IMIE vs. CPIA; high satisfaction score; 63.2% vs. 87.2%, P=0.001). The incidence of unintended deep sedation was significantly higher in the IMIE Group compared to the CPIA Group (IMIE vs. CPIA; 17.1% vs. 5.1%, P=0.018) as well as the number of patients showing spontaneous movement or those requiring physical restraint (IMIE vs. CPIA; spontaneous movement; 60.5% vs. 42.3%, P=0.024, physical restraint; 27.6% vs. 10.3%, P=0.006, respectively). In contrast, level of satisfaction of the patients were found to be significantly higher in the IMIE Group (IMIE vs. CPIA; high satisfaction score; 85.5% vs. 67.9%, P=0.027). Pain scores of the patients, hemodynamic and respiratory events, and ESD outcomes and complications were not different between the two groups.
CONCLUSION
Continuous propofol and remifentanil infusion by an anesthesiologist during ESD can increase the satisfaction levels of the endoscopists by providing a more stable state of sedation.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01806753.
背景
尽管内镜黏膜下剥离术（ESD）通常在镇静状态下进行，但不同镇静方法对ESD操作的影响尚不清楚。本研究旨在前瞻性地评估和比较两种镇静方法在ESD过程中内镜医师的满意度和患者稳定性。
方法
154例计划行ESD的成年患者分别采用内镜医师间歇性注射咪达唑仑/丙泊酚（IMIE）或麻醉医师持续输注丙泊酚（CPIA）的方法进行镇静。本研究的主要终点是比较两组内镜医师的满意度。次要终点包括患者满意度、患者疼痛评分、影响操作的事件、意外深度镇静的发生率、血流动力学和呼吸事件，以及ESD结果和并发症。
结果
与IMIE组相比，CPIA组内镜医师的满意度显著更高（IMIE组与CPIA组；高满意度评分；63.2%对87.2%，P=0.001）。IMIE组意外深度镇静的发生率显著高于CPIA组（IMIE组与CPIA组；17.1%对5.1%，P=0.018），以及出现自主运动或需要身体约束的患者数量（IMIE组与CPIA组；自主运动；60.5%对42.3%，P=0.024，身体约束；27.6%对10.3%，P=0.006）。相反，发现IMIE组患者的满意度显著更高（IMIE组与CPIA组；高满意度评分；85.5%对67.9%，P=0.027）。两组患者的疼痛评分、血流动力学和呼吸事件，以及ESD结果和并发症无差异。
结论
麻醉医师在ESD期间持续输注丙泊酚和瑞芬太尼可通过提供更稳定的镇静状态提高内镜医师的满意度。
试验注册
ClinicalTrials.gov NCT01806753。
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